gms | German Medical Science

Background: Oxaliplatin (Eloxatin®) is used in the adjuvant and palliative treatment of colorectal cancer. It is currently available as lyophilisate, which has to be reconstituted prior to infusion. A ready-to-use oxaliplatin solution has been developed in order to facilitate administration of oxaliplatin.

Objectives: Primary aim of the study was to compare the 2 preparations with regard to the time for preparing a standard oxaliplatin infusion. Secondary aims were comparisons with regard to material costs and waste disposal as well as the overall assessment of the pharmacists.

Methods: The time as well as all materials used for each preparation step of a standard infusion with the approved dose (85 mg/m²) were recorded (for a patient with a body surface area of 1.75m² ). For each infusion 2 oxaliplatin vials containing 100mg and 50mg, respectively, were used. The lyophilisate (L) was reconstituted and then diluted, whereas the solution (S) only had to be diluted. Assuming an effect size of 1, i.e., a 90-second reduction in preparation time with a standard deviation of 90sec, a sample size of n=23 for each preparation has a power of 90% to detect such a difference with a type I error of 0.05 (2-sided). After a practice session it was planned to prepare 46 infusions in each of the 2 participating pharmacies (one hospital pharmacy and one public pharmacy).

Results: In each of the 2 pharmacies 25 infusions were prepared with the lyophilisate (L) and 27 with the solution (S). The mean preparation times were 114±8sec (L) vs. 70±7sec (S) in center1 and 134±13sec (L) vs. 81±8sec (S) in center2. The mean differences were 44±8sec and 54±11sec, respectively. These differences were highly significant in both centers (p<0.000001). In both centers the preparation time was reduced by about 40% when the solution was used. No relevant differences were observed for the dilution times and thus the differences in preparation times were mainly due to the reconstitution of the lyophilisate. Savings with regard to material costs and the reduction in waste very much depend on local procedures. Both pharmacists appreciated the facilitation of the preparation process.

Conclusions: The newly developed oxaliplatin solution leads to a 40%-reduction in preparation time for a standard infusion.